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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Regulatory Affairs Senior Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for formulating and communicating the regulatory promotional position for approved and/or pipeline Oncology products and disease state.

Responsibilities:

• Provide strategic direction for product and disease communications and associated activities by interpreting current regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public

• Serve as a regulatory advertising and promotion lead for approved and/or pipeline Oncology product and disease state  

• Ensuring deliverables are consistent with the product label, compliant with US FDA regulations and guidance, and adhere to Amgen SOPs and policies

• Identifying opportunities and challenges that impact US product strategy based upon evolving competition, regulatory environment, and clinical data

• Experienced in evaluating appropriate levels of evidence to make product claims

• Mentor Manager level promotional reviewers

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of industry experience OR

• Master’s degree and 6 years of industry experience OR

• Bachelor’s degree and 8 years of industry experience OR

Preferred Qualifications

• 2 years experience in Oncology

• Experience in interpretation of government regulations, policies, and guidance

• Strong clinical data analysis skills

• Ability to use judgement and data to formulate and communicate positions on complex issues

• Experience collaborating within large cross-functional teams

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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